Surmodics’ Pounce Thrombectomy System Evaluated in Infrainguinal Subset From PROWL Registry

November 2, 2024—Surmodics, Inc. recently announced early results from its PROWL registry study of a subset of 60 real-world patients with acute, subacute, and chronic limb ischemia treated with the company’s Pounce thrombectomy system.

According to Surmodics, PROWL is an open-label, retrospective, multicenter, United States registry of the Pounce platform for the nonsurgical removal of emboli and thrombi in the peripheral arterial vasculature.

Dean Ferrera, DO, presented the data from the analysis of the infrainguinal PROWL subset of 60 patients treated with the Pounce thrombectomy system, which is indicated for use in peripheral arteries from 3.5 to 6 mm in diameter.

Dr. Ferrera presented the subset results at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

The company stated that the PROWL registry is collecting real-world efficacy and safety outcomes data for endovascular interventions using the fully mechanical, nonaspiration-based Pounce thrombectomy platform for up to 500 patients at up to 30 sites. The core lab-adjudicated study is enrolling all patients treated with the Pounce Platform, including those with shortened life expectancy, history of cancer or COVID-19, and those with previous interventions to the target limb.

The analysis examined patients with symptomatic native, infrainguinal vessels, followed through 30 days.

As summarized in Surmodics’ press release, the results demonstrate the following:

• 90% procedural success—defined as restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment (patient-level success).
• 96.8% of patients experienced final post-procedural TIPI 2-3 blood flow restoration.
• 80.8% technical success—defined as restoration of blood flow to the target lesion(s) with <50% residual obstruction without the need to initiate catheter-directed therapies or to proceed to open surgery or other endovascular thrombectomy devices (lesion-level success).
• 81.7% of patients (49 of 60) received no further thromboemboli removal treatment within 30 days post Pounce system use.
• 1.7% of patients (1 of 60) experienced device-related adverse events, showing the product was well tolerated.

The company further noted that previous studies of aspiration thrombectomy for symptomatic limb ischemia excluded patients with symptom duration > 14 days or patients whose thrombi or emboli were not fresh.

In the 60-patient PROWL cohort, 60% of patients presented with acute (≤ 14 days) limb ischemia, 16.7% presented with subacute (15-28 days) limb ischemia, and 23.3% presented with chronic (> 28 days) limb ischemia. Additionally, 66.7% of patients avoided an intensive-care unit admission and 81.7% were discharged home, reported Surmodics.

The national coprincipal investigators of the PROWL registry study are Sean Lyden, MD, and Joseph Campbell, MD. Dr. Lyden is Chairman of the Department of Vascular Surgery at the Cleveland Clinic in Cleveland, Ohio. Dr. Campbell is an interventional cardiologist at OhioHealth in Columbus, Ohio.

“Although patients with limb ischemia often seek care acutely, many patients present after experiencing symptoms for several days or weeks,” commented Dr Campbell in the company’s press release. “As a result, operators are often challenged to remove clots of mixed morphology and chronicity, which may impact procedural success rates both with thrombolytic and primary aspiration strategies.”

Dr. Campbell continued, “These early PROWL results suggest that the Pounce thrombectomy system is effective as a standalone solution for removing acute-to-chronic clot in real-world clinical settings without use of adjunctive thrombolytics, aspiration devices, or surgery.”

He added, “In terms of health care resource utilization, the high rate of ICU avoidance and discharge home in this very ill population is encouraging. We’re eagerly awaiting further results from this highly promising registry study.”

Surmodics stated that the Pounce thrombectomy platform includes the Pounce thrombectomy system, Pounce LP low-profile thrombectomy system, and the Pounce XL thrombectomy system.

All three are FDA-cleared, fully mechanical thrombectomy devices designed to promptly remove organized thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment. They are indicated for use in peripheral arteries 3.5 to 6 mm, 2 to 4 mm, and 5.5 to 10 mm in diameter, respectively. The Pounce XL thrombectomy system is currently pending commercial release, advised the company.